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Linggui Yangyuan Paste for patients with male infertility: a study protocol for a multicenter, double-blind, double-dummy, randomized controlled trial

Linggui Yangyuan Paste for patients with male infertility: a study protocol for a multicenter, double-blind, double-dummy, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068556
Enrollment
Unknown
Registered
2023-02-23
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

male infertility (asthenozoospermia and oligoasthenozoospermia)

Interventions

treatment group:Ling-Gui-Yang-Yuan Gel and Wu-Zi-Yan-Zong oral solution mimetics

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Study participants met the diagnostic criteria for male infertility (2) Study participants met the diagnostic criteria for AZS or OA (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms

Exclusion criteria

Exclusion criteria: (1)infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders (2)with infertility caused by organic lesions of the reproductive system (3)with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection (4)with palpable varicocele (5)with abnormal and clinical significance of sex hormone (FSH, LH, T) (6)complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases (7)with a history of allergy to any medicine or ingredients used in this study (8)receive other relevant treatment for the disease 2 weeks before treatment

Design outcomes

Primary

MeasureTime frame
TPMSC;

Secondary

MeasureTime frame
semen parameters (SV?SC?SPE-C?PR?PR+NP?TPMSC/UV);TCM symptoms scores;pregnancy rate;time to pregnancy;

Countries

China

Contacts

Public ContactGuo jun

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

guojun1126@126.com+86 10 62835134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026